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FDA 510(k)

REVOLUTION 45MHZ IVUS IMAGING CATHETER

K-Number: K080891 · 2008-05-12

ApplicantVolcano Corporation
Decision Date2008-05-12
Product CodeOBJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

REVOLUTION 45MHZ IVUS IMAGING CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Volcano Corporation. It received FDA 510(k) clearance on 2008-05-12 under 510(k) number K080891. The device is classified under product code OBJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REVOLUTION 45MHZ IVUS IMAGING CATHETER?

REVOLUTION 45MHZ IVUS IMAGING CATHETER is a medical device that received FDA 510(k) clearance on 2008-05-12. The listed applicant is Volcano Corporation. The 510(k) number is K080891.

When did REVOLUTION 45MHZ IVUS IMAGING CATHETER receive FDA 510(k) clearance?

REVOLUTION 45MHZ IVUS IMAGING CATHETER received FDA 510(k) clearance on 2008-05-12, under 510(k) number K080891.

Who is the listed applicant for REVOLUTION 45MHZ IVUS IMAGING CATHETER?

The FDA 510(k) record lists Volcano Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for REVOLUTION 45MHZ IVUS IMAGING CATHETER?

The FDA product code for REVOLUTION 45MHZ IVUS IMAGING CATHETER is OBJ.

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Related Devices (Code: OBJ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261696ACUNAV Luxera 4D ICE CatheterSiemens Medical Solutions USA, Inc.K261849VERAFEYE Imaging Catheter (VF-VIC-002)Luma Vision LimitedK252945Novasight Hybrid SystemConavi Medical, Inc.K260816OptiCross Coronary Imaging Catheter (H749518110); OptiCross 6 Coronary Imaging Catheter (H7495181160); OptiCross HD Coronary Imaging Catheter (H74939352040); OptiCross 6 HD Coronary Imaging Catheter (H74939354080); OptiCross Coronary Imaging Catheter (Bagless) (H749518130); OptiCross 6 Coronary Imaging Catheter (Bagless) (H7495181360); OptiCross HD Coronary Imaging Catheter (Bagless) (H74939352050); OptiCross 6 HD Coronary Imaging Catheter (Bagless) (H74939354090)Boston ScientificK253399Visions® PV .014P RX Digital IVUS Catheter ; Visions® PV .018 Digital IVUS CatheterVolcano Corporation (Dba Philips Image Guided Therapy DeviceK250955XC11 ICE System, USAYorlabs, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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